tlast (Common) [Regulatives / Guidelines]

posted by ElMaestro  – Belgium?, 2019-02-21 18:02 (644 d 21:24 ago) – Posting: # 19963
Views: 5,775

Hi again,

» Let's play devel's advocate for a moment and assume, AUC tlast fails, but AUC common tlast is OK (besides the fact that in 80% Cmax should fail alone or in combination with AUC, but....). And you can show a high number of non-common tlast (equally distributed between T and R). No way forward, or?

Would likely be accepted in Sweden :-D

I could be wrong, but...

Best regards,
ElMaestro

No, of course you do not need to audit your CRO if it was inspected in 1968 by the agency of Crabongostan.

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